Medical Device EMC Risk Management

occounty

Involved In Discussions
#1
Hi,
I am new to risk management in general and hence new to EMC Risk management too.
IEC 60601-1-2 provides an annex to go over the concept in general of risk management from EMC point of view but was wondering if there is a good starting point that anyone else is aware about.

I would appreciate any suggestions/comments on how to deal with this requirement.

Thank you!
 
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yodon

Staff member
Super Moderator
#2
Not completely sure I understand your question. Do you have a copy of / are you conducting risk management per ISO 14971? That would be your starting point for the whole risk management process. 60601-1-2, when addressing risk, I believe is primarily in terms of effects of EMI/EMC and impact to the essential performance. Your baseline risk analysis supports the identification of essential performance. Then you can assess risks considered in 60601-1-2.
 

Jean_B

Trusted Information Resource
#3
This gives context and references: Risk Management of Medical Devices Regarding Electromagnetic Disturbances | In Compliance Magazine

Too long, didn't (want to) read: Currently IEC 61000-1-2:2016's Annex B is the most up-to-date publication, superseding the old guidance by applying the method from IEC 61508 functional safety as state-of-the-art (with some additions to the 2013 guidance).
The amendment to IEC 60601-1-2 set for 2019 would include similar specific to medical devices.

Note that the above article is definitely worth the time to read, but I respect everyone's (lack of) time so provided a summary. It doesn't do the author's (Keith Armstrong) work much justice though.
 

QAengineer13

Quite Involved in Discussions
#4
Hi,
I am new to risk management in general and hence new to EMC Risk management too.
IEC 60601-1-2 provides an annex to go over the concept in general of risk management from EMC point of view but was wondering if there is a good starting point that anyone else is aware about.

I would appreciate any suggestions/comments on how to deal with this requirement.

Thank you!
In addition to Yodon's and Jean's comment, I am not sure whether you are familiar with this FDA guidance, its worth a read as welll

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM470201.pdf
 
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